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Pioglitazone, Body Composition,Insulin Sensitivity and Protein Metabolism in ESRD

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2007 by Centre Hospitalier Universitaire Vaudois.
Recruitment status was:  Recruiting
Information provided by:
Centre Hospitalier Universitaire Vaudois Identifier:
First received: December 3, 2010
Last updated: NA
Last verified: February 2007
History: No changes posted

Non diabetic patients on renal replacement therapy are prone to changes in body composition with an increase in visceral fat and muscle wasting all favoured by the insulin resistant state. Malnutrition is associated with a worst prognosis in these patients. Glitazones are the most powerful insulin sensitisers available in clinical practice which also have anti-inflammatory properties. Their use has been associated with significant and favourable changes in body fat distribution in type 2 diabetic subjects. Experimental studies suggest that glitazones may attenuate muscle wasting in renal failure.

The goal of this study was to examine in non diabetic ESRD patients the effects of pioglitazone on inulin sensitivity and protein metabolism as determined by the hyperinsulinemic euglycemic clamp and on changes in body composition as determined by anthropometric measurements, dual energy X-ray absorptiometry (DEXA) and CT-scan determined changes in abdominal visceral and sub-cutaneous fat.

Condition Intervention Phase
Drug: Pioglitazone
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Pioglitazone on Body Composition,Insulin Sensitivity and Protein Metabolism in ESRD Non Diabetic Individuals

Resource links provided by NLM:

Further study details as provided by Centre Hospitalier Universitaire Vaudois:

Primary Outcome Measures:
  • Body composition [ Time Frame: at the end of each treatment phase (which lasts 4 months) ]
    Effect of pioglitazone on the body composition determined by DEXA, abdominal CT, anthropometric measurements.

  • Insulin sensitivity [ Time Frame: at the end of each treatment phase (which lasts 4 months) ]
    Hepatic and whole body insulin sensitivity will be determined during the insulin glucose clamp.

  • Protein metabolism [ Time Frame: at the end of each treatment phase (which lasts 4 months) ]
    Protein turnover will be determined by leucine infusion during the insulin glucose clamp

Estimated Enrollment: 16
Study Start Date: March 2007
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Pioglitazone 45mg per day
Pioglitazone 45mg qd will be added to the current treatment
Drug: Pioglitazone
45mg qd for 4 months
Other Name: Actos 45mg P05W8
Placebo Comparator: placebo
placebo qd will be added to current treatment
Drug: Pioglitazone
45mg qd for 4 months
Other Name: Actos 45mg P05W8


Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

Non diabetic individuals with ESRD, on hemodialysis or peritoneal dialysis for at least 3 months. Consent form signed -

Exclusion Criteria:

No infectious complication 3 months prior to entry in the study.

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Please refer to this study by its identifier: NCT01253928

Nephrology Service Department of Medicine CHUV Recruiting
Lausanne, Vaud, Switzerland, 1011
Contact: Anne Zanchi, MD    41 21 314 11 54   
Principal Investigator: Anne Zanchi, MD         
Sponsors and Collaborators
Centre Hospitalier Universitaire Vaudois
Principal Investigator: Anne Zanchi, MD CHUV Lausanne
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Anne Zanchi MD, CHUV Identifier: NCT01253928     History of Changes
Other Study ID Numbers: 224/05
Study First Received: December 3, 2010
Last Updated: December 3, 2010

Keywords provided by Centre Hospitalier Universitaire Vaudois:
body composition
insulin sensitivity
protein metabolism

Additional relevant MeSH terms:
Insulin Resistance
Immune System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Hypoglycemic Agents
Physiological Effects of Drugs processed this record on May 22, 2017